FDA approval of HypoCath
| Reference number | |
| Coordinator | MICROPOS MEDICAL AB (PUBL) - Micropos Medical AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | September 2020 - November 2020 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Skills enhancement in small businesses - 2020 |
Important results from the project
FDA approval of RayPilot with HypoCath
Expected long term effects
510k certificate with possibilities of market introduction in the US
Approach and implementation
The work has been run by our QA / RA responsible person. In consultation with an FDA consultant, we have systematically reviewed our documentation and updated it to comply with the requirements and wording required by the FDA. New clinical validation and verification has also taken place. We have currently arrived at the work step of compiling all documentation in accordance with the regulations and rules required by the FDA.